Entheogen is a biotechnology company developing BOL-148 for cluster headache, a terrible condition worse than migraine where the current standard treatments are abortive medications that often provide limited effectiveness and potential toxicity. People with chronic cluster headache suffer multiple attacks for at least 11-months out of the year, which sometimes leads to suicide. Desperate for relief, thousands of sufferers use LSD and psilocybin mushrooms, which they have found more helpful than prescription medications.
Two psychiatrists with deep expertise in psychedelic research theorized that such relief was not attributable to hallucinogenicity but rather that something else was taking place. Dr. John Halpern of Harvard’s McLean Hospital and Dr. Torsten Passie of Medizinische Hochschule Hannover in Germany began investigating and eventually patenting BOL-148, an unscheduled non-psychedelic analog of LSD-25, as an alternative. In 2010, Mr. Ari Mello, an entrepreneur, was brought in and together the 3-partners formed Entheogen.
In 2008 under compassionate use, they conducted an open label clinical study involving 8 chronic patients who each received 3-pills over 10-days and were then headache-free for 4-18 months with no lasting side effects! These results would be remarkable for any condition but given the untreatable nature and poorly understood mechanism of action of cluster headache, the results point to a potential major breakthrough that could end the cycle of suffering.
Entheogen needs money to conduct additional preclinical studies in order to file an Investigational New Drug application (IND) with the F.D.A., which will allow us to conduct our next human clinical trial. This includes dosing and toxicology studies that demonstrate what we already firmly belive: that BOL-148 will prove to be a very safe medicine. The company raised $350,000 from private investors, which was spent on international patent filings. In 2011 we received an $8 million Venture Capital offer and in 2012 we received a $19 million VC offer. While both deals were countersigned, they failed to complete by no fault of BOL-148 or Entheogen but rather by factors beyond our control. Having struggled raising money through the credit crisis and now facing another long due diligence process with a new VC, Entheogen is seeking private support to speed up getting BOL-148 to the people who desperately need it.
BOL-148 was discovered by Albert Hofmann in the 1950s at Sandoz Labs and was initially used as a placebo in LSD trials where it was safely administered to 300 people and often in very large doses. BOL-148 is distinct from LSD and is not criminally Scheduled or on a forensic chemical watch list, and there is little probability that it could become a substance of abuse. As time is running out to develop this medicine, our success with this crowd funding drive will determine whether BOL-148 becomes available in the future to improve the lives of millions of people or whether it is never approved for human use.
We intend to apply the money we raise to clinically advancing BOL-148. Entheogen is a “virtual company,” meaning we have no physical office or lab and therefore next to zero overhead and instead outsource work to consultants and contract research organizations. None of the funds will be used for any payments to the founders, who have not received any salary or fees for the past 3.5-years. We anticipate patent and legal expenses of up to $100,000 over the next 12-months and consulting fees of up to $100,000. The remainder of the money will be paid to contract research organizations who will conduct preclinical IND-enabling studies, which must be completed before another human trial can launch.
To this end Entheogen has a top tier team of consultants and advisers. This includes several highly accomplished experts in headache and neuropathic pain, senior drug development industry veterans, and doctors who have conducted or been involved in hundreds of clinical trials. We are also in close contact with a couple thousand patients and many of the top pain clinics that treat cluster headache.
With new data in hand we can apply to FDA for our IND, clearing us to conduct Phase I/II studies in humans with a target of 100 people. If we exceed our funding goal we may be able to begin human trials, with an expected cost of around $25,000 per patient. Should we fail to raise our full target amount, we will use the funds for as many of the lower cost studies as possible. This moves the development forward and makes our case stronger as we speak to investors. We will also maintain the patents and use our consultants as minimally as possible. Even with less than our full fund raise, we expect it will buy us enough time to identify a new investor and complete their due diligence.
In the meantime, over the next 12-months we will aggressively seek new investors to fund larger trials. We will also speak to big pharmaceutical companies about partnering with us on further development. This funding round buys us the time to achieve either of those goals, and puts essential data in our hands to significantly improve the prospect of BOL-148 development.
As we move forward, we will continue to update our website (www.entheogencorp.com) on our progress. We will also add a page to recognize everyone who helps make BOL-148 available. We have created 5-categories for contributors, and we will list your name so that people know you helped make a difference. If you prefer not to have your name listed, we will post it as “Anonymous.”
Drug development is a strange world with a powerful buddy network that can empower projects or completely ignore them at a whim. Crazy ideas with little validation or true prospect attract giant investment while promising therapeutics suffer a seemingly endless string of rejection and negativity. Entheogen’s partners have endured countless hours of unpaid work and have survived several situations that appeared hopeless, and it has been our firm conviction that BOL-148 is safe, effective, and desperately needed by many people who suffer beyond imagination. Their personal lives and careers are frequently destroyed, and every day many of them question why they should hang in there. Having connected with a few thousand patients who believe in BOL-148 as fervently as we do, our belief in this work is unshakeable.
Even with our limited data we have undergone diligence and come close to striking development deals with two big pharmaceutical companies, who remain interested and have invited us back to the table with more data. Once we complete our next round of studies, it will be their money and expertise that carries BOL-148 across the finish line. Over time, the work we do today will literally improve the lives of millions of people. Many of these people have shattered lives because the pain is so debilitating, and once BOL-148 is approved they will be able to repair or build new relationships, and return to living productive lives. Since we began Entheogen several of the people we have known have committed suicide, and we believe BOL-148 will put a stop to this.
We hope you will help us to balance the playing field and give the small guy a chance. We are passionately convinced that BOL-148 is one of the most important medicines being developed, and we need all the support we can get. We need to move forward just a little and then we are unstoppable, because BOL-148 will do all the rest. Anything you can do to help our fund raise be successful will make a huge difference. Even if money is too tight, taking a few minutes to share this link with friends and family, or providing links to the Indiegogo share tools will help our drive go viral. Your participation will make a big difference, and on behalf of cluster patients around the world we thank you for your time and consideration.